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J Clin Oncol. 2016 Mar 20;34(9):953-62. doi: 10.1200/JCO.2015.64.8824. Epub 2016 Jan 25.

PROCLAIM: Randomized Phase III Trial of Pemetrexed-Cisplatin or Etoposide-Cisplatin Plus Thoracic Radiation Therapy Followed by Consolidation Chemotherapy in Locally Advanced Nonsquamous Non-Small-Cell Lung Cancer.

Author information

1
Suresh Senan, VU Medical Center, Amsterdam; Bonne Biesma, Jeroen Bosch Hospital, 's-Hertogenbosch; and Joachim Aerts, Erasmus MC Rotterdam/Amphia Hospital Breda, Breda, the Netherlands; Anthony Brade, Princess Margaret Hospital, University of Toronto; Neill Iscoe, Eli Lilly Canada, Toronto, Ontario, Canada; Lu-hua Wang, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Tony Mok, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, People's Republic of China; Johan Vansteenkiste, University Hospital KU Leuven, Leuven, Belgium; Shaker Dakhil, Cancer Center of Kansas, Wichita, KS; Ramaswamy Govindan, Washington University School of Medicine, Saint Louis, MO; David Gandara, University of California, Davis Health System, Sacramento, CA; Hak Choy, UT Southwestern Medical Center, Dallas, TX; Anwar Hossain, Joseph Treat, and Andrew Koustenis, Eli Lilly and Company, Indianapolis, IN; Everett Vokes, University of Chicago, Chicago, IL; Maite Martinez Aguillo, Hospital of Navarre, Irunlarrea, Pamplona; Belén Rubio-Viqueira, Hospital Universitario Quirón Madrid; and Bélen San Antonio, Eli Lilly and Company, Madrid, Spain; Conrad Lewanski, Charing Cross Hospital, London, United Kingdom; and Nadia Chouaki, Eli Lilly and Company, Neuilly-sur-Seine, France. s.senan@vumc.nl.
2
Suresh Senan, VU Medical Center, Amsterdam; Bonne Biesma, Jeroen Bosch Hospital, 's-Hertogenbosch; and Joachim Aerts, Erasmus MC Rotterdam/Amphia Hospital Breda, Breda, the Netherlands; Anthony Brade, Princess Margaret Hospital, University of Toronto; Neill Iscoe, Eli Lilly Canada, Toronto, Ontario, Canada; Lu-hua Wang, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Tony Mok, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, People's Republic of China; Johan Vansteenkiste, University Hospital KU Leuven, Leuven, Belgium; Shaker Dakhil, Cancer Center of Kansas, Wichita, KS; Ramaswamy Govindan, Washington University School of Medicine, Saint Louis, MO; David Gandara, University of California, Davis Health System, Sacramento, CA; Hak Choy, UT Southwestern Medical Center, Dallas, TX; Anwar Hossain, Joseph Treat, and Andrew Koustenis, Eli Lilly and Company, Indianapolis, IN; Everett Vokes, University of Chicago, Chicago, IL; Maite Martinez Aguillo, Hospital of Navarre, Irunlarrea, Pamplona; Belén Rubio-Viqueira, Hospital Universitario Quirón Madrid; and Bélen San Antonio, Eli Lilly and Company, Madrid, Spain; Conrad Lewanski, Charing Cross Hospital, London, United Kingdom; and Nadia Chouaki, Eli Lilly and Company, Neuilly-sur-Seine, France.

Abstract

PURPOSE:

The phase III PROCLAIM study evaluated overall survival (OS) of concurrent pemetrexed-cisplatin and thoracic radiation therapy (TRT) followed by consolidation pemetrexed, versus etoposide-cisplatin and TRT followed by nonpemetrexed doublet consolidation therapy.

PATIENTS AND METHODS:

Patients with stage IIIA/B unresectable nonsquamous non-small-cell lung cancer randomly received (1:1) pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) intravenously every 3 weeks for three cycles plus concurrent TRT (60 to 66 Gy) followed by pemetrexed consolidation every 3 weeks for four cycles (arm A), or standard therapy with etoposide 50 mg/m(2) and cisplatin 50 mg/m(2) intravenously, every 4 weeks for two cycles plus concurrent TRT (60 to 66 Gy) followed by two cycles of consolidation platinum-based doublet chemotherapy (arm B). The primary objective was OS. The study was designed as a superiority trial with 80% power to detect an OS hazard ratio of 0.74 with a type 1 error of .05.

RESULTS:

Enrollment was stopped early because of futility. Five hundred ninety-eight patients were randomly assigned (301 to arm A, 297 to arm B) and 555 patients (283 in arm A, 272 in arm B) were treated. Arm A was not superior to arm B in terms of OS (hazard ratio, 0.98; 95% CI, 0.79 to 1.20; median, 26.8 v 25.0 months; P = .831). Arm A had a significantly lower incidence of any drug-related grade 3 to 4 adverse events (64.0% v 76.8%; P = .001), including neutropenia (24.4% v 44.5%; P < .001), during the overall treatment period.

CONCLUSION:

Pemetrexed-cisplatin combined with TRT followed by consolidation pemetrexed was not superior to standard chemoradiotherapy for stage III unresectable nonsquamous non-small-cell lung cancer.

PMID:
26811519
DOI:
10.1200/JCO.2015.64.8824
[Indexed for MEDLINE]

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